Steroids Found Effective in Reducing Severe Sore Throat Pain

Embargoed until May 11, 2001

Contact: Kenneth S. Satterfield760-776-8502 (5/11-5/16) 703- 519-1563[email protected]

Steroids Found Effective in Reducing Severe Sore Throat Pain

A single dose of Detxamethasone provides faster, inexpensive relief

Palm Desert, CA ö Pharyngitis (sore throat) is the third most common complaint of patients seeking physician care. Pharyngitis and respiratory tract illness are the major causes of emergency room antibiotic use, and the management costs of pharyngitis alone account for over $300 million annually in the United States.

Despite physiciansâ long-standing familiarity with pharyngitis, wide variability exists in the treatment approach. Controversies persist over patient selection for throat cultures and antibiotic treatment, use of new rapid diagnostic tests for streptococcal disease, and occurrence of bacteriologic and clinical failure with penicillin treatment of group A beta hemolytic streptococci (GABHS).

Both the physician and patient seek the same result: immediate relief for the severe pain associated with pharyngitis and successful treatment in the long run. Now, a new study states that a single dose of the steroid dexamethasone, administered by injection or pill, offers earlier onset of pain relief. Study subjects were completely pain-free after 12-24 hours with no complications. Researchers concluded that a pill form of the steroid is easier for patients to tolerate and reduces the need for doctor/nurse administration of an injection.

A team of Mayo Clinic researchers conducted a prospective, randomized, double-blinded, placebo-controlled clinical trial for patients, 15 years or older, who presented acute pharyngitis to the Emergency Department, seeking medical attention for sore throat, odynophagia (pain on swallowing), and/or dysphagia (difficulty in swallowing). Note: A double-blinded study does not allow the researcher nor any other assessor of the results, including patients, to know which group is subject to which procedure.

The authors of the study, Efficacy of Single Dose Dexamethasone as Adjuvant Therapy for Acute Pharyngitis, are Julie L. Wei MD and Jan L. Kasperbauer MD from the Department of Otorhinolaryngology, Andrew J. Boggust, MD, Department of Emergency Medicine, and Amy L. Weaver, M.S., Department of Biostatistics, all from the Mayo Clinic, Rochester, MN. Their findings were presented May 16, 2001, before the meeting of the Triological Society, in Palm Desert, CA.

Methodology

Study sample: Patients were included if their physical examination confirmed erythema (redness of the skin due to capillary dilation) with or without exudate in the oropharynx, with a clinical diagnosis of acute pharyngitis or tonsillitis. Causes for exclusion were: age less than 15, history of immunosuppression (e.g., liver transplant, chemotherapy), history of diabetes mellitus, HIV-positive status, history of head and neck malignancy, recent steroid use (less than 3 months) or chronic oral steroid use, status post adenotonsillectomy (within 3 months), return visit to the Emergency Department for same complaint but not initially enrolled, suspected peritonsillar abscess, required hospitalization due to dehydration, and unable to follow-up by telephone.

Data Collection: The primary end point of evaluation was the change in a patientâs subjective rating of his or her throat pain. Patients were asked to rate their pain on a visual analogue scale (VAS) from one to 10, with one being no pain and 10 being the worst pain imaginable. Upon enrollment, demographics, presenting symptoms, and the pain VAS were recorded. Phone follow-ups were performed as closely to 12 hours and 24 hours post treatment as possible.

Treatment Protocol: Each patient received both a pill (PO) as well as an intramuscular (IM)

injection. A randomization procedure was prepared for the pharmacy, which provided for each patient, upon enrollment, a pill and an intramuscular injection for treatment. The Emergency Department physician administering the treatment was blinded to the content of the treatment. Three treatment arms were included in the randomization: (1) IM = IM dexamethasone (10mg), PO placebo; (2) PO = PO dexamethasone (10mg), IM placebo; and (3) placebo = PO and IM placebo. Each subject was empirically treated for bacterial pharyngitis with a 10 day course of penicillin VK 500mg three times a day or erythromycin 333mg three times a day if there was a penicillin allergy.

Differences between the three treatment arms were evaluated based on the chi-square test orFisherâs exact test for nominal scaled variables (e.g., complete resolution) and the Kruskal-Wallis test for ordinal or continuously scaled variables (e.g. change in pain VAS, time until onset of pain relief).

Results: From August 1998 to July 2000, a total of 118 patients were enrolled. Thirty-seven received the placebo, 39 a 10 mg single dose of IM injection of dexamethasone (n=39), and 42 a 10 mg single dose of PO dexamethasone. All patients received oral antibiotics. Bacterial throat cultures were obtained from every patient.

Complete telephone follow-up 12 hours after treatment was available in 111 patients, and 24-hour

follow-up data was available in 116 patients. The change (pre-treatment minus 12-hour follow-up) in the pain VAS scores reported by patients who received either IM (median, 4; mean + SD, 4.2+2.3) or PO dexamethasone (median, 3; 3.8+2.3) was significantly greater than the patients who received placebo (median, 2; 2.1+2.0; p<0.001 and p=0.002, respectively). This difference in improvement was evident when the percent change was compared between the three treatment arms at the 12-hour and 24-hour follow-up assessments. Patients receiving dexamethasone experienced the onset of pain relief a median of four hours earlier than patients who received PO and IM placebo (p=0.029).

Conclusions: The study found that: (1) dexamethasone as an adjunctive treatment for acute pharyngitis is safe, and well tolerated; (2) dexamethasone at a 10 mg dose, administered IM or PO, significantly contributes to pain relief and return of patient activity level in acute pharyngitis; (3) Dexamethasone may be more effective for treating pharyngitis caused by identifiable bacterial pathogen(s); and (4) Routinely prescribing a 10 mg dose of dexamethasone (IM or PO) in conjunction with an antibiotic would significantly benefit recovery from acute pharyngitis, preventing potential hospitalization for dehydration and oral intake intolerance- end -. Editorâs Note: Send reprint request to Dr. Andrew J. Boggust, Department of Emergency Medicine, Mayo Clinic, 1216 Second St. S.W., Saint Marys Hospital, Rochester MN 55902